Preliminary establishment of HIL alert indices and allowable ranges of sample volume for automatic coagulation analysis line in laboratory
10.13602/j.cnki.jcls.2023.12.02
- VernacularTitle:全自动凝血分析流水线HIL指数报警阈值和体积探测允许范围的初步建立
- Author:
Weiling SHOU
1
;
Qian CHEN
;
Cheng XIANG
;
Yueming TANG
;
Wei WU
Author Information
1. 中国医学科学院北京协和医学院北京协和医院检验科,北京 100730
- Keywords:
coagulation screening test;
pre-analytical quality control;
HIL index;
volume check
- From:
Chinese Journal of Clinical Laboratory Science
2023;41(12):886-890
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish hemolysis-icterus-lipemia(HIL)alert indices and allowable ranges of sample volume check in CS5100 and CN6000 automated coagulation analyzers.Methods The samples of interference substances were prepared by using the interference reagent kit or obtained through artificial freeze and suction.Twenty-one samples with various concentrations of interference substances were used to evaluate repeatability of HIL indices,and 206 such samples were used to evaluate the consistency of HIL indi-ces between two different instrument systems.A total of 425 specimens were collected to evaluate the concentration distribution of inter-fering substances with various HIL indices,and 378 specimens were used to evaluate the consistency of HIL indices between manual assessment and instrumental operation.Six coagulation screening tests were analyzed parallelly for the samples prepared with the artifi-cial interference before and after,and the HIL indices were recorded.The differences between the paired samples with different concen-trations of interference substances were compared,and the HIL alert indices in different detection intervals of each test were deter-mined.Ten tubes of samples with standard volume±10％lower and upper limits were prepared using distilled water to establish the al-lowable range of volume check for each instrument,and 2 933 samples were used to validate the established ranges.Results The re-peatabilities of the HIL indices in the two systems were favorable,and the consistency between the two systems was fine(Kappa values were 0.969,0.978 and 0.991,respectively,P=0.000).The consistency between instrumental and manual assessment for the evalua-tion of hemolytic samples was just average level(Kappa values were 0.421 to 0.702,P＜0.001).The consistency for jaundice samples between instrumental and manual assessment was poor(Kappa values were 0.023 to 0.267),except the P=0.258 between the operator 1 and instrument,all the other operators were remaining P＜0.001.The consistency between instrumental and manual assessment for chyle samples was better(Kappa values 0.559 to 0.838,P＜0.001).The HIL alert indices varied with different intervals of detection for each test.The APTT H alert index was significantly lower than that measured in other tests when ordinary heparin was used in anti-co-agulation monitoring.The allowable ranges of volume check in 5 coagulation analyzers were 41.0 to 55.5 mm,44.3 to 58.4 mm,41.3 to 56.2 mm,58.3 to 72.5 mm and 59.2 to 73.3 mm respectively.Conclusion The HIL alert indices and allowable range of volume check were determined preliminarily for coagulation screening tests in various detection intervals of two different systems in our laboratory,which provided the basis for achieving intelligent management of pre-analytical quality control.
